Zimmer Dental Recalls Try-In Abutments Due to Missing Supplemental Instructions
Zimmer Biomet is recalling specific dental try-in abutments because they were shipped with standard instructions but lacked required supplemental instructions.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to missing documentation (supplemental IFUs) rather than a physical defect or contamination, which aligns with the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Zimmer Biomet is conducting a medical device field correction for various dental products, specifically try-in abutments and kits. The affected products include specific reference numbers such as ZOAT34, ZOAT45, ZOAT56, and ZOATKIT.
The recall is being conducted because several parts were shipped to customers with only standard Instructions for Use (IFUs). All affected products were missing the required supplemental IFUs. This documentation issue affects 76 products distributed across the United States, Canada, and numerous international locations including France, Japan, and Australia.
Consumers and healthcare providers should stop using the affected products and contact Zimmer Dental Inc for further instructions regarding the missing documentation.
The recalled product
- Product
- TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT56; TRY-IN KIT, ABUTMENT, CONT, REF ZOATKIT
- Manufacturer
- Zimmer Dental Inc
- Hazard
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- lot # 63145351
- 63202941
- 60646055
- 62353334
- 63316134
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Zimmer Dental Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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